Ignite Creation Date:
2024-05-06 @ 2:37 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04379999
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2020-01-03
Brief Title:
Atorvastatin Aspirin in Lynch Syndrome Syndrome
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Impact of Atorvastatin Aspirin on Colorectal Biomarkers in Patients With Lynch Syndrome a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to investigate that a common cholesterol lowering agent atorvastatin alone or combining with a nonsteroidal anti-inflammatory drug aspirin would reduce the risk of colorectal cancer CRC in high-risk individuals with Lynch syndrome
Detailed Description:
This is an exploratory biomarker trial to assess the ability of atorvastatin common cholesterol lowering agent alone or combining with aspirin a nonsteroidal anti-inflammatory drug to reduce the risk of colorectal cancer in high-risk individuals with Lynch Syndrome Subjects will be stratified based on their prior history of polypscancer to receive atorvastatin without or with aspirin for 6 weeks Blood and normal colon biopsies will be obtained at Day 0 and at 6 weeks on study Tissue endpoints for analysis include cell proliferation apoptosis and changes in gene expression Circulating lipid profiles and metabolic function and post-treatment questionnaires will be used to assess the acceptability of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None